
Atorvastatin Calcium
CAS number: 134523-03-8
Molecular formula: C66H68CaF2N4O10
molecular weight: 1155.36
Chemical structure:
Producers shown on SFDA
(Record date:01/09/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Haisen Pharmaceutical Co., Ltd. | GMP | Valid till August 2021 |
Zhejiang Lepu Pharmaceutical Co., Ltd. | GMP, DMF | Valid till February 2024 |
Zhejiang Hongyuan Pharmaceutical Co., Ltd. | GMP, DMF | Valid till March 2023 |
Shijiazhuang Pharmaceutical Group Huasheng Pharmaceutical Co., Ltd | GMP | Valid till February 2018 |
Tianjin Jialin Medical Co., Ltd. | GMP | Valid till July 2023 |
Wuhan Zy Pharmaceutical Co., Ltd. | GMP | Valid till January 2019 |
Zhejiang Jiangbei Pharmaceutical Co., Ltd. | GMP | Valid till November 2024 |
Hunan Dino Pharmaceutical Co., Ltd. | GMP | Valid till May 2021 |
Zhejiang Hisun Pharmaceutical Co., Ltd. | GMP | Valid till April 2022 |
Beijing Jialin Pharmaceutical Co., Ltd. | GMP | Valid till December 2017 |
Jiangsu Hengrui Medicine Co.,Ltd. | GMP | Valid till November 2020 |
Topfond Pharmaceutical Co., Ltd. | GMP | Valid till December 2020 |
Producers shown on EP
(Quoted from EP website;record date:01/09/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Atorvastatin calcium trihydrate Form-I | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2011-222-Rev 00 | 04/06/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | Changzhou Pharmaceutical Factory CN 213 018 Jiangsu Province | R0-CEP 2015-034-Rev 01 | 17/01/2017 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Form I, ATN process | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R0-CEP 2020-092-Rev 00 | 01/10/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2012-035-Rev 00 | 19/07/2019 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2011-068-Rev 01 | 22/02/2018 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process-IV | CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar | R0-CEP 2021-079-Rev 00 | 05/07/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2011-013-Rev 00 | 29/09/2017 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | HEC PHARM GMBH DE 10963 Berlin | R0-CEP 2012-382-Rev 01 | 23/11/2015 | WITHDRAWN BY HOLDER | 30/10/2017 | Chemistry |
Atorvastatin calcium trihydrate Micronised | MOREPEN LABORATORIES LIMITED IN 110 001 New Delhi | R1-CEP 2012-179-Rev 03 | 21/05/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | Zhejiang Hisun Pharmaceutical Co., Ltd. CN 318 000 Taizhou City | R0-CEP 2013-339-Rev 00 | 19/11/2014 | WITHDRAWN BY HOLDER | 15/10/2020 | Chemistry |
Atorvastatin calcium trihydrate | ZHEJIANG JIANGBEI PHARMACEUTICAL CO., LTD. CN 318 017 Taizhou City | R1-CEP 2014-160-Rev 00 | 25/03/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | KRKA d.d. SI 8501 Novo Mesto | R1-CEP 2013-024-Rev 01 | 28/05/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | SANECA PHARMACEUTICALS A.S. SK 920 27 Hlohovec | R0-CEP 2015-271-Rev 00 | 28/06/2017 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Crystalline | BIOCON LIMITED IN 560 100 Bengaluru | R1-CEP 2011-009-Rev 02 | 22/04/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process II | CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar | R1-CEP 2011-156-Rev 03 | 31/03/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | ZHEJIANG LEPU PHARMACEUTICAL CO.,LTD CN 318 000 Taizhou City | R1-CEP 2012-139-Rev 01 | 31/08/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai | R1-CEP 2014-206-Rev 00 | 09/06/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process I | CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar | R1-CEP 2011-181-Rev 01 | 02/03/2018 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | MYLAN LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2011-184-Rev 01 | 16/06/2017 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. NL 2613 AX Delft | R1-CEP 2010-366-Rev 03 | 16/06/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | LUPIN LIMITED IN 400 055 Mumbai | R0-CEP 2014-145-Rev 02 | 10/12/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process-III | CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar | R0-CEP 2020-309-Rev 00 | 19/02/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate AS | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R0-CEP 2018-059-Rev 01 | 12/12/2019 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | Ind-Swift Laboratories Limited IN 160 101 Chandigarh | R1-CEP 2011-234-Rev 02 | 12/05/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Form-I | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2018-049-Rev 00 | 02/04/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | NINGBO MENOVO PHARMACEUTICAL CO., LTD. CN 315 040 Ningbo Hi-Tech District | R0-CEP 2019-013-Rev 00 | 24/09/2020 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process-IV | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 2013-094-Rev 01 | 25/02/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate Process II | Ind-Swift Laboratories Limited IN 160 101 Chandigarh | R0-CEP 2021-102-Rev 00 | 25/06/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram | R0-CEP 2015-288-Rev 02 | 08/07/2021 | VALID | / | Chemistry |
Atorvastatin calcium trihydrate | ZHEJIANG HONGYUAN PHARMACEUTICAL CO., LTD. CN 317 016 Duqiao | R0-CEP 2017-158-Rev 01 | 13/08/2021 | VALID | / | Chemistry |
Producer:Zhejiang Haisen Pharmaceutical Co., Ltd., located in Liushi street, Dongyang City, is a national high-tech enterprise engaged in the R & D, production and operation of APIs and pharmaceutical intermediates. The company covers an area of 70000 square meters and has more than 400 employees, including professional technicians More than 30%.
The company passed ISO9001:2000 international quality system certification in 2001. It passed the domestic GMP certification for the first time in 2006, obtained the EU CEP Certificate in the same year, and passed the on-site audit of FDA for the first time in 2014. At present, many varieties have been registered in the United States, the European Union, Japan, South Korea, India, Brazil, Mexico and other countries. Among them, sucralfate products account for more than 60% of the world market.
Staff size:400-499 persons
Registered capital:RMB 51 million
Producer:Zhejiang Lepu Pharmaceutical Co., Ltd., established in 2001, is located in Jiaojiang block, Taizhou chemical API Industrial Park, Zhejiang Province. Covering an area of nearly 300 mu, the company is a core subsidiary of Lepu (Beijing) medical device company.
The company attaches great importance to product quality and has successively passed GMP certification and registration such as China nm-pa, US FDA, EU EDQM, Japan PMDA and Korea KFDA. Many varieties occupy a leading position in the world.
The company's marketing network covers five continents and has established partnerships with nearly 600 customers at home and abroad in more than 70 countries and regions. Many products lead the sales in the international market, among which the sales of main varieties of atorvastatin calcium account for more than 50% of the world.
Staff size:700-799 persons
Registered capital:RMB 160 million
Producer:Zhejiang Hongyuan Pharmaceutical Co., Ltd., established in 2005, is a member of Zhongda Group Co., Ltd., one of the world's top 500 enterprises, and a holding subsidiary of Wuchang Chemical Group Co., Ltd.
The company has an experienced management team, has established a relatively standardized and perfect quality management system and EHS management system, and has passed the acceptance of national GMP certification, standardization certification, cleaner production, three Simultaneities and professional control evaluation.
Staff size:300-399 persons
Registered capital:RMB 29.5 million
Producer:The company has been cancelled
Staff size:/
Registered capital:RMB 4 million
Producer:Tianjin Jialin Pharmaceutical Co., Ltd., established on September 7, 2011, is subordinate to Beijing Jialin Pharmaceutical Co., Ltd.
Staff size:100-199 persons
Registered capital:RMB 100 million
Producer:Wuhan Zy Pharmaceutical Co., Ltd., established in April 2009 and located in Gedian Economic and Technological Development Zone, Ezhou City, Hubei Province, is a modern generic drug R & D and API production enterprise in line with FDA and cGMP. The investment in phase I is RMB 300 million, covering an area of 172 Mu and phase II is 200 mu, totaling 372 mu. In October 2013, it obtained the drug production license of Wuhan Zhongyou Pharmaceutical Co., Ltd. and successfully obtained the 2010 GMP certificate of atorvastatin calcium and fasudil mesylate. It is an export-oriented high-end pharmaceutical raw material production base based on the EHS requirements of ISO and OSHA and the cGMP standards of FDA and EU, and will be subject to the official cGMP inspection of FDA and EU. At present, it has been successfully exported to the United States, Europe, India and other international markets.
Staff size:100-199 persons
Registered capital:RMB 30 million
Producer:Zhejiang Jiangbei Pharmaceutical Co., Ltd., founded in July 1993, is a private enterprise focusing on the production of APIs, intermediates and solid preparations. At present, simvastatin, atorvastatin and levetiracetam have successively passed the official inspection and certification of FDA, CEP, who, Japan, South Korea and India, and passed the new version of GMP inspection in China.
Staff size:300-399 persons
Registered capital:36 million 124 thousand and 417
Producer:Hunan Dino Pharmaceutical Co., Ltd., founded in 1997, formerly from Hunan Pharmaceutical Industry Research Institute, is a modern growth high-tech enterprise engaged in the production and marketing of medicine and raw materials. At present, the company has two GMP certified modern pharmaceutical bases in Liuyang and Changsha, including more than ten dosage forms and 14 production lines, such as tablets, capsules, ointments, dry suspensions, pellets, small volume injections, chemical synthetic APIs and oral liquids. Strictly control "quality" and establish a quality assurance system in line with international quality supervision concepts such as FDA, ICH and EDQM.
Staff size:800-899 persons
Registered capital:RMB 17.876059 million
Producer:Zhejiang Hisun Pharmaceutical Co., Ltd. was founded in 1956. In 2000, Hisun issued A-shares in Shanghai stock exchange, but it continues to remain a state-owned enterprise. Hisun is one of the largest antibiotics and anti-tumor drug production bases in the country. It has won several titles, including first batch of innovative enterprises, national technology innovation demonstration enterprises, and "National Industrial Brand Demonstration Enterprise” of the Chinese Ministry of Industry and Information Technology.
Hisun began as a small chemical factory and entered the pharmaceutical field in the early 1970s. Since its founding over 60 years ago in 1956, Hisun has amassed a total asset worth of 21.8 billion RMB. While Hisun is primarily engaged in the R&D, manufacturing, and sales and marking of API and final dosage forms of chemical and biological drugs, its core business has extended to include branded generic drugs, biosimilarst and other innovative drugs.
Staff size:About 9000 persns
Registered capital:RMB 1 billion 169 million
Producer:Beijing Jialin Pharmaceutical Co., Ltd., established in December 1998, is a high-tech enterprise appointed by Beijing Science and Technology Commission and a wholly-owned subsidiary of dezhanda health Co., Ltd.
The company has invested more than 50 million yuan to build an oral solid preparation workshop, antitumor drug workshop, fine drying charter room, drug warehouse supporting production and scientific research, central laboratory and inspection center in line with the national GMP standard on the basis of the original plant. The plant covers an area of 41021 square meters and a construction area of 12170 square meters. Annual production capacity: 700 million tablets; 200 million capsules; 5 million bags of granules; 90000 tons of raw materials. The enterprise has increased the software and hardware construction of the production quality system and passed the national GMP certification.
Registered capital:RMB 30.5 million
Producer:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs.
The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan
The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.
Staff size:About 30000 persons
Registered capital:RMB 6 billion 397 million
Producer:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.
Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.
Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.
Staff size:2000-2999 persons
Registered capital:RMB 420 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978